Aesthet Surg J. 2023 Apr 11:sjad098. doi: 10.1093/asj/sjad098. Online ahead of print.
ABSTRACT
BACKGROUND: Breast Implant Illness (BII) describes a variety of symptoms reported by patients with breast implants. Biospecimens data revealed minimal statistical differences between BII and Non-BII cohorts. Baseline analysis of PROMIS data demonstrated significant differences between the BII Cohort and the two control cohorts.
OBJECTIVES: This study was designed to determine if subjects in the BII Cohort obtained any symptom improvement after explantation, whether symptom improvement was related to the type of capsulectomy, and which symptoms improved.
METHODS: A prospective blinded study enrolled 150 consecutive subjects divided equally into three cohorts. Baseline demographic data and a systemic symptoms survey, including PROMIS validated questionnaires, was obtained at baseline, 3-6 weeks, 6 months, and one year.
RESULTS: 150 patients were enrolled between 2019-2021. Follow-up at one year is 94% of BII Cohort and 77% of Non-BII and Mastopexy Cohorts. At one year, 88% of patients showed at least partial symptom improvement with a reduction of 2-20 symptoms. The PROMIS score in the BII Cohort decreased at one year for anxiety, sleep disturbances, and fatigue. Systemic symptom improvement was noted out to one year in the BII Cohort regardless of the type of capsulectomy performed.
CONCLUSIONS: Parts 1-3 in this series concluded there were no consistent differences in biospecimen results between the cohorts. Unlike the data observed in the biospecimen analysis, BII subjects had heightened symptoms and poorer PROMIS scores at baseline compared to the control cohorts. The reduction of negative expectations and a potential nocebo effect could contribute to this improvement.
PMID:37040435 | DOI:10.1093/asj/sjad098
